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A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

NCT01278407•Eisai Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with Lewy bodies (DLB).

Detailed Description

This 52-week study consisted of 16-week randomized placebo-controlled (RCT, including 12-week Confirmatory Phase) and 36-week open-label extension phases. Of 142 DLB patients enrolled in the RCT phase (three arms: placebo, 5 mg, and 10 mg), 110 entered the extension phase. The placebo group of the RCT phase initiated active treatment at week 16, and the active groups maintained allocated treatment and dosages until week 24. After week 24, all patients received 10 mg. Dose reduction to 5 mg for safety concerns was allowed.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients diagnosed as probable dementia with Lewy bodies (DLB) according to the consensus diagnostic criteria for DLB
•2. Patients having caregivers throughout the study who submited written consent to cooperate with this study, who routinely stayed with patients 3 days or more a week (at least 4 hours a day), provided patients' information necessary for this study, assisted treatment compliance, and escorted the patients on required visits to study institution
•3. Clinical Dementia Rating (CDR) score ≥ 0.5
•4. Mini-Mental State Examination (MMSE) score of 10 to 26

Exclusion Criteria

•1. Patients diagnosed with Parkinson's disease with dementia (PDD)
•2. Patients who received anti-dementia drug therapy at the same institution
•3. Patients who received anti-dementia drug therapy within 12 weeks before start of Screening
•4. Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, or a history of brain surgery causing unrecovered deficiency
•5. Patients with severe extrapyramidal disorders (Hoehn and Hahr staging score ≥ IV)
•6. Patients whose systolic blood pressure was less than 90 mmHg or pulse rate was less than 50 bpm at screening

Locations (56)

Anjo-shi, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Toyokawa-shi, Aichi-ken, Japan

Chiba, Chiba, Japan

Fukui-shi, Fukui, Japan

Yoshida-gun, Fukui, Japan

Fukuoka, Fukuoka, Japan

Kitakyushu-shi, Fukuoka, Japan

Omuta-shi, Fukuoka, Japan

Gifu, Gifu, Japan

Key Dates

Start Date

February 1, 2011

Primary Completion Date

March 1, 2013

Completion Date

April 1, 2013

Last Updated

June 29, 2023

Enrollment

142

ACTUAL participants

Conditions

Dementia With Lewy Bodies (DLB)

Interventions

Donepezil 5 mg

DRUG

Donepezil 10 mg

DRUG

Donepezil matched placebo

DRUG

Retrospective Observational Study of Blood-based Biomarkers in the Diagnosis and Monitoring of Patients With a Neurodegenerative Disease or Mental Disorder

NCT07314190

Alzheimer DiseaseDementia With Lewy Bodies (DLB)+5 more

View study

COMPLETEDPHASE2

A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies

NCT00598650

Dementia With Lewy Bodies (DLB)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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